Type 2 Diabetes Clinical Trial
— LixiLan-LOfficial title:
A Randomized, 30-week, Active-controlled, Open Label, 2- Treatment Arm, Parallel-group, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine With or Without Metformin in Patients With Type 2 Diabetes Mellitus (T2DM)
Verified date | July 2016 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Primary Objective:
To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination
to insulin glargine in HbA1c change from baseline to week 30.
Secondary Objective:
To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio
combination to insulin glargine (with or without metformin) over a 30 week treatment period
in patients with type 2 diabetes
Status | Completed |
Enrollment | 736 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria : - Type 2 diabetes mellitus diagnosed at least 1 year before the screening visit. - Treatment with basal insulin for at least 6 months before the screening visit. - Stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection) for at least 3 months before the screening visit. - Stable (plus/minus 20 percent) total daily basal insulin dose between 15 and 40 Units/day for at least 2 months prior to the screening visit. - For patients receiving basal insulin AND 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months before the screening visit. The OADs can be 1 to 2 out of: - metformin (more than or equal to1500mg/day or maximal tolerated dose), - a sulfonylurea - a glinide, - a dipeptidyl-peptidase-4 inhibitor - a sodium glucose co-transporter 2 inhibitor - Fasting plasma glucose (FPG) less than or equal to 180 mg/dL(10.0 mmol/L) at screening visit for patients receiving basal insulin in combination with 2 OADs or with 1 OAD other than metformin; FPG less than or equal to 200 mg/dL (11.1 mmol/L) at screening visit for patients on basal insulin only or basal insulin plus metformin at screening visit, - Signed written informed consent. Exclusion criteria: - Age under legal age of adulthood at screening visit - HbA1c at screening visit less than 7.5% or above 10%. - Pregnancy or lactation, women of childbearing potential with no effective contraceptive method. - Use of other oral or injectable glucose-lowering agents than stated in the inclusion criteria in a period of 3 months prior to screening. - Previous use of insulin other than basal insulin eg, prandial or pre-mixed insulin, in the year prior to screening. Note: Short term treatment (=10 days) due to intercurrent illness is allowed. - History discontinuation of a previous treatment with Glucagon Like Peptide -1 Receptor Agonists for safety/tolerability or lack of efficacy. - Patient who has previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide fixed ratio combination or has previously received lixisenatide. - Use of weight loss drugs within 3 months prior to screening visit. - Within the last 6 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period. - History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery. - Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes). - Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 95 mmHg) at screening visit - At screening visit, Body Mass Index (BMI) less than or equal to 20 or above 40 kg/m² - At screening visit amylase and/or lipase more than 3 times the upper limit of the normal (ULN) laboratory range, - At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 3 ULN - At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L) - Any contraindication to metformin use, according to local labeling, if the patient is taking metformin. - Patient who has a renal function impairment with creatinine clearance less than 30 mL/min (using the Cockcroft and Gault formula) or end-stage renal disease for patients, not treated with metformin. Exclusion criteria for randomization: - HbA1c less than 7% or above 10% . - Mean fasting Self Measured Plasma Glucose (SMPG) calculated from the self-measurements for 7 days the week before randomization visit is above 140 mg/dL (7.8 mmol/L). - Average insulin glargine daily dose less than 20 Units or above 50 Units ( in the week before randomization visit). - Amylase and/or lipase more than 3 ULN . The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Investigational Site Number 036505 | Box Hill | |
Australia | Investigational Site Number 036501 | Heidelberg | |
Australia | Investigational Site Number 036504 | Parkville | |
Canada | Investigational Site Number 124504 | Beamsville | |
Canada | Investigational Site Number 124512 | Brampton | |
Canada | Investigational Site Number 124502 | Guelph | |
Canada | Investigational Site Number 124507 | Kelowna | |
Canada | Investigational Site Number 124505 | Montreal | |
Canada | Investigational Site Number 124511 | Oakville | |
Canada | Investigational Site Number 124509 | St-Romuald | |
Canada | Investigational Site Number 124503 | Toronto | |
Canada | Investigational Site Number 124510 | Toronto | |
Canada | Investigational Site Number 124501 | Vancouver | |
Canada | Investigational Site Number 124508 | Victoria | |
Chile | Investigational Site Number 152511 | Puerto Varas | |
Chile | Investigational Site Number 152501 | Santiago | |
Chile | Investigational Site Number 152502 | Santiago | |
Chile | Investigational Site Number 152503 | Santiago | |
Chile | Investigational Site Number 152507 | Santiago | |
Chile | Investigational Site Number 152514 | Santiago | |
Chile | Investigational Site Number 152509 | Talagante | |
Chile | Investigational Site Number 152513 | Temuco | |
Chile | Investigational Site Number 152504 | Vina Del Mar | |
Czech Republic | Investigational Site Number 203502 | Cheb | |
Czech Republic | Investigational Site Number 203504 | Hranice | |
Czech Republic | Investigational Site Number 203507 | Krnov | |
Czech Republic | Investigational Site Number 203506 | Liberec | |
Czech Republic | Investigational Site Number 203503 | Olomouc | |
Czech Republic | Investigational Site Number 203514 | Plzen | |
Czech Republic | Investigational Site Number 203515 | Plzen | |
Czech Republic | Investigational Site Number 203511 | Praha 4 | |
Czech Republic | Investigational Site Number 203508 | Praha 5 | |
Czech Republic | Investigational Site Number 203509 | Praha 8 | |
Czech Republic | Investigational Site Number 203505 | Prostejov | |
Denmark | Investigational Site Number 208503 | Aarhus C | |
Denmark | Investigational Site Number 208509 | Horsens | |
Denmark | Investigational Site Number 208501 | København Nv | |
Denmark | Investigational Site Number 208505 | København S | |
Denmark | Investigational Site Number 208502 | Kolding | |
Denmark | Investigational Site Number 208504 | Viborg | |
Estonia | Investigational Site Number 233502 | Pärnu | |
Estonia | Investigational Site Number 233503 | Tallinn | |
Estonia | Investigational Site Number 233501 | Tartu | |
Hungary | Investigational Site Number 348501 | Budapest | |
Hungary | Investigational Site Number 348503 | Budapest | |
Hungary | Investigational Site Number 348505 | Budapest | |
Hungary | Investigational Site Number 348502 | Debrecen | |
Hungary | Investigational Site Number 348506 | Kaposvár | |
Hungary | Investigational Site Number 348504 | Pápa | |
Lithuania | Investigational Site Number 440501 | Kaunas | |
Lithuania | Investigational Site Number 440503 | Kaunas | |
Lithuania | Investigational Site Number 440505 | Kedainiai | |
Lithuania | Investigational Site Number 440504 | Klaipeda | |
Lithuania | Investigational Site Number 440502 | Vilnius | |
Mexico | Investigational Site Number 484508 | Celaya | |
Mexico | Investigational Site Number 484501 | Cuernavaca | |
Mexico | Investigational Site Number 484503 | Guadalajara | |
Mexico | Investigational Site Number 484504 | Guadalajara | |
Mexico | Investigational Site Number 484506 | Guadalajara | |
Mexico | Investigational Site Number 484509 | México | |
Mexico | Investigational Site Number 484507 | Pachuca | |
Mexico | Investigational Site Number 484505 | Puebla | |
Netherlands | Investigational Site Number 528505 | Almere | |
Poland | Investigational Site Number 616502 | Bialystok | |
Poland | Investigational Site Number 616505 | Krakow | |
Poland | Investigational Site Number 616506 | Krakow | |
Poland | Investigational Site Number 616507 | Plock | |
Poland | Investigational Site Number 616504 | Szczecin | |
Poland | Investigational Site Number 616501 | Warszawa | |
Poland | Investigational Site Number 616503 | Warszawa | |
Romania | Investigational Site Number 642507 | Brasov | |
Romania | Investigational Site Number 642510 | Bucharest | |
Romania | Investigational Site Number 642508 | Bucuresti | |
Romania | Investigational Site Number 642509 | Bucuresti | |
Romania | Investigational Site Number 642506 | Hunedoara | |
Romania | Investigational Site Number 642505 | Iasi | |
Romania | Investigational Site Number 642502 | Oradea | |
Romania | Investigational Site Number 642511 | Sibiu | |
Romania | Investigational Site Number 642501 | Targu Mures | |
Romania | Investigational Site Number 642503 | Timisoara | |
Romania | Investigational Site Number 642504 | Timisoara | |
Russian Federation | Investigational Site Number 643511 | Arkhangelsk | |
Russian Federation | Investigational Site Number 643512 | Moscow | |
Russian Federation | Investigational Site Number 643508 | Penza | |
Russian Federation | Investigational Site Number 643501 | Saint-Petersburg | |
Russian Federation | Investigational Site Number 643513 | Samara | |
Russian Federation | Investigational Site Number 643507 | Saratov | |
Russian Federation | Investigational Site Number 643514 | Saratov | |
Russian Federation | Investigational Site Number 643502 | St-Petersburg | |
Russian Federation | Investigational Site Number 643503 | St-Petersburg | |
Russian Federation | Investigational Site Number 643504 | St-Petersburg | |
Russian Federation | Investigational Site Number 643506 | St-Petersburg | |
Russian Federation | Investigational Site Number 643505 | St. Petersburg | |
Russian Federation | Investigational Site Number 643509 | Voronezh | |
Slovakia | Investigational Site Number 703505 | Bratislava | |
Slovakia | Investigational Site Number 703507 | Bytca | |
Slovakia | Investigational Site Number 703502 | Kosice | |
Slovakia | Investigational Site Number 703510 | Kosice | |
Slovakia | Investigational Site Number 703512 | Kosice | |
Slovakia | Investigational Site Number 703511 | Lubochna | |
Slovakia | Investigational Site Number 703508 | Moldava Nad Bodvou | |
Slovakia | Investigational Site Number 703504 | Nove Mesto Nad Vahom | |
Slovakia | Investigational Site Number 703509 | Nove Zamky | |
Slovakia | Investigational Site Number 703513 | Trnava | |
Slovakia | Investigational Site Number 703501 | Zilina | |
Spain | Investigational Site Number 724509 | Alicante | |
Spain | Investigational Site Number 724506 | Alzira | |
Spain | Investigational Site Number 724504 | Barcelona | |
Spain | Investigational Site Number 724510 | Barcelona | |
Spain | Investigational Site Number 724505 | Cáceres | |
Spain | Investigational Site Number 724503 | El Ferrol | |
Spain | Investigational Site Number 724508 | La Coruña | |
Spain | Investigational Site Number 724501 | Sabadell | |
Spain | Investigational Site Number 724507 | Segovia | |
Spain | Investigational Site Number 724502 | Valencia | |
Sweden | Investigational Site Number 752501 | Ljungby | |
Sweden | Investigational Site Number 752503 | Malmö | |
Sweden | Investigational Site Number 752504 | Rättvik | |
Sweden | Investigational Site Number 752506 | Stenungssund | |
Sweden | Investigational Site Number 752505 | Stockholm | |
Sweden | Investigational Site Number 752502 | Vällingby | |
Ukraine | Investigational Site Number 804501 | Chernivtsi | |
Ukraine | Investigational Site Number 804507 | Kyiv | |
Ukraine | Investigational Site Number 804510 | Kyiv | |
Ukraine | Investigational Site Number 804511 | Kyiv | |
Ukraine | Investigational Site Number 804513 | Lviv | |
Ukraine | Investigational Site Number 804502 | Vinnytsya | |
Ukraine | Investigational Site Number 804508 | Vinnytsya | |
United States | Investigational Site Number 840576 | Albuquerque | New Mexico |
United States | Investigational Site Number 840605 | Amarillo | Texas |
United States | Investigational Site Number 840580 | Arlington Heights | Illinois |
United States | Investigational Site Number 840594 | Atlanta | Georgia |
United States | Investigational Site Number 840582 | Aurora | Colorado |
United States | Investigational Site Number 840553 | Austin | Texas |
United States | Investigational Site Number 840598 | Austin | Texas |
United States | Investigational Site Number 840543 | Avon | Indiana |
United States | Investigational Site Number 840520 | Baltimore | Maryland |
United States | Investigational Site Number 840560 | Baltimore | Maryland |
United States | Investigational Site Number 840568 | Bell Gardens | California |
United States | Investigational Site Number 840607 | Birmingham | Alabama |
United States | Investigational Site Number 840613 | Burlington | Vermont |
United States | Investigational Site Number 840558 | Butte | Montana |
United States | Investigational Site Number 840622 | Charleston | South Carolina |
United States | Investigational Site Number 840504 | Chesapeake | Virginia |
United States | Investigational Site Number 840519 | Chicago | Illinois |
United States | Investigational Site Number 840612 | Chicago | Illinois |
United States | Investigational Site Number 840550 | Chino | California |
United States | Investigational Site Number 840529 | Chula Vista | California |
United States | Investigational Site Number 840579 | Columbus | Ohio |
United States | Investigational Site Number 840614 | Columbus | Georgia |
United States | Investigational Site Number 840623 | Corona | California |
United States | Investigational Site Number 840502 | Corpus Christi | Texas |
United States | Investigational Site Number 840530 | Dallas | Texas |
United States | Investigational Site Number 840545 | Dallas | Texas |
United States | Investigational Site Number 840547 | Dallas | Texas |
United States | Investigational Site Number 840586 | Dallas | Texas |
United States | Investigational Site Number 840601 | Dallas | Texas |
United States | Investigational Site Number 840524 | Dayton | Ohio |
United States | Investigational Site Number 840505 | Dearborn | Michigan |
United States | Investigational Site Number 840509 | Denver | Colorado |
United States | Investigational Site Number 840512 | Draper | Utah |
United States | Investigational Site Number 840541 | Durham | North Carolina |
United States | Investigational Site Number 840554 | Edinburg | Texas |
United States | Investigational Site Number 840618 | Eugene | Oregon |
United States | Investigational Site Number 840565 | Evansville | Indiana |
United States | Investigational Site Number 840585 | Evansville | Indiana |
United States | Investigational Site Number 840615 | Evansville | Indiana |
United States | Investigational Site Number 840571 | Federal Way | Washington |
United States | Investigational Site Number 840575 | Flint | Michigan |
United States | Investigational Site Number 840566 | Fresno | California |
United States | Investigational Site Number 840552 | Greenbrae | California |
United States | Investigational Site Number 840604 | Greenville | North Carolina |
United States | Investigational Site Number 840600 | Henderson | Nevada |
United States | Investigational Site Number 840540 | Hickory | North Carolina |
United States | Investigational Site Number 840544 | Houston | Texas |
United States | Investigational Site Number 840514 | Hurst | Texas |
United States | Investigational Site Number 840588 | Idaho Falls | Idaho |
United States | Investigational Site Number 840507 | Indianapolis | Indiana |
United States | Investigational Site Number 840563 | Indianapolis | Indiana |
United States | Investigational Site Number 840583 | Jamaica | New York |
United States | Investigational Site Number 840578 | Lancaster | California |
United States | Investigational Site Number 840532 | Las Vegas | Nevada |
United States | Investigational Site Number 840599 | Las Vegas | Nevada |
United States | Investigational Site Number 840501 | Lawrenceville | Georgia |
United States | Investigational Site Number 840595 | Lewiston | Maine |
United States | Investigational Site Number 840517 | Little Rock | Arkansas |
United States | Investigational Site Number 840537 | Little Rock | Arkansas |
United States | Investigational Site Number 840581 | Los Angeles | California |
United States | Investigational Site Number 840626 | Los Angeles | California |
United States | Investigational Site Number 840516 | Louisville | Kentucky |
United States | Investigational Site Number 840503 | Maumee | Ohio |
United States | Investigational Site Number 840510 | Miami | Florida |
United States | Investigational Site Number 840546 | Milwaukee | Wisconsin |
United States | Investigational Site Number 840564 | Minneapolis | Minnesota |
United States | Investigational Site Number 840621 | Mission Viejo | California |
United States | Investigational Site Number 840513 | Morehead City | North Carolina |
United States | Investigational Site Number 840591 | Murray | Utah |
United States | Investigational Site Number 840617 | N Richland Hill | Texas |
United States | Investigational Site Number 840539 | Nashua | New Hampshire |
United States | Investigational Site Number 840531 | New Hyde Park | New York |
United States | Investigational Site Number 840521 | New Port Richey | Florida |
United States | Investigational Site Number 840561 | Norfolk | Virginia |
United States | Investigational Site Number 840625 | Norfolk | Virginia |
United States | Investigational Site Number 840511 | Northridge | California |
United States | Investigational Site Number 840602 | Ocala | Florida |
United States | Investigational Site Number 840538 | Ocoee | Florida |
United States | Investigational Site Number 840526 | Ogden | Utah |
United States | Investigational Site Number 840506 | Omaha | Nebraska |
United States | Investigational Site Number 840597 | Orem | Utah |
United States | Investigational Site Number 840534 | Palm Harbor | Florida |
United States | Investigational Site Number 840573 | Palm Springs | California |
United States | Investigational Site Number 840610 | Philadelphia | Pennsylvania |
United States | Investigational Site Number 840559 | Port Hueneme | California |
United States | Investigational Site Number 840611 | Rapid City | South Dakota |
United States | Investigational Site Number 840606 | Richmond | Virginia |
United States | Investigational Site Number 840522 | Rockville | Maryland |
United States | Investigational Site Number 840525 | Roswell | Georgia |
United States | Investigational Site Number 840608 | Salem | Virginia |
United States | Investigational Site Number 840592 | Salisbury | North Carolina |
United States | Investigational Site Number 840590 | Salt Lake City | Utah |
United States | Investigational Site Number 840536 | San Ramon | California |
United States | Investigational Site Number 840567 | Santa Ana | California |
United States | Investigational Site Number 840551 | Smithfield | Pennsylvania |
United States | Investigational Site Number 840593 | Spokane | Washington |
United States | Investigational Site Number 840556 | Springfield | Illinois |
United States | Investigational Site Number 840570 | Sun City | Arizona |
United States | Investigational Site Number 840557 | Syracuse | New York |
United States | Investigational Site Number 840609 | Tacoma | Washington |
United States | Investigational Site Number 840569 | Tarzana | California |
United States | Investigational Site Number 840562 | Tempe | Arizona |
United States | Investigational Site Number 840584 | Tipton | Pennsylvania |
United States | Investigational Site Number 840577 | Tucson | Arizona |
United States | Investigational Site Number 840572 | West Hills | California |
United States | Investigational Site Number 840535 | Wilmington | North Carolina |
United States | Investigational Site Number 840549 | Wilmington | Delaware |
United States | Investigational Site Number 840515 | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
United States, Australia, Canada, Chile, Czech Republic, Denmark, Estonia, Hungary, Lithuania, Mexico, Netherlands, Poland, Romania, Russian Federation, Slovakia, Spain, Sweden, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in HbA1c from baseline | week 30 | No | |
Secondary | Percentage of patients reaching HbA1c targets | week 30 | No | |
Secondary | Change in 2-hour Post Prandial Glucose and in blood glucose excursion during standardized meal test from baseline to week 30 | week 30 | No | |
Secondary | Change in body weight from baseline | week 30 | No | |
Secondary | Change in 7-point Self-Monitoring Plasma Glucose profiles from baseline | week 30 | No | |
Secondary | Change in daily dose of insulin glargine from baseline | week 30 | No | |
Secondary | Change in Fasting Plasma Glucose from baseline | week 30 | No | |
Secondary | Documented (plasma glucose less than or equal to 70 mg/dl) symptomatic hypoglycemia | 30 weeks | Yes | |
Secondary | Severe symptomatic hypoglycemia | 30 weeks | Yes |
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